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Genetic Engineering
Report for the Ticino Medical Tribunal
Urs Guthauser, 1997

Deutsch - from EVU News, Issue 2 /1997- Italiano

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Dr. Urs Guthauser, Doctors for the Protection of the Environment, via Ubrio 2, 6616 Losone, Switzerland
Tel.: +41 (0)91 756 71 11
Fax: +41 (0)91 752 27 26
e-mail: uguthau@dial.eunet.ch

Summary:
Genetic engineering is currently being strongly promoted for scientific, medical and economic reasons. In only 20 years, we have reached such a high level of development in this technology that we can now make crucial changes to nature. We hope to gain even further insight into the processes of life itself, to develop new and more efficient therapies for serious illnesses and to access new markets with large margins of profit through genetic engineering. However, this may lead to potential dangers associated with genetic engineering being overlooked or underestimated. For instance, economic interests dictate the dissemination of genetically engineered plants as well as the production and patenting of transgenetic animals for the production of food and medication without any prior reliable risk evaluation and technology assessment.

In addition to this, the use of transgenetic animals in medical research represents a very controversial method - from a scientific as well as from an ethical and moral point of view. Only now is technology assessment for genetic engineering taking place and any kind of risk evaluation is virtually impossible for the time being. Understandably, there is a very low level of acceptance of genetic engineering among consumers. The aim of this report is to take a critical look at the ecological, health-related, economic, socio-political and ethical implications of genetic engineering and to discuss the limits and dangers of genetic engineering. We believe that it is the duty of society at large to set clear limits to industry and science in the application of genetic engineering and thus demand a critical public discourse in which every interested party should partake.

Introduction:
Science, politics and society today face tremendous environmental problems (1,2). Many diseases (AIDS, BSE, Alzheimer’s disease, cancer etc.) present an overwhelming challenge to medical research. In spite of tremendous efforts, we still have not found efficient therapies for a large number of diseases. Thus, medical research is placing great hopes in biotechnology. Genetic engineering makes it possible for mankind to influence the environment to an unpredictable extent. We have thus reached a degree of influence on the environment which is no longer subject to the laws of nature and evolution. Today, we can make fundamental changes to the processes of life itself, accelerate the slow, gradual, natural adaptation which takes place during natural evolution, overstep the limits represented by species and according to the wishes of humans, create new living beings which serve only the consumer interests of man.

The underlying philosophical and scientific attitude has its foundations in the reductionist and mechanistic mentality of Descartes, the philosopher, and Newton, the physicist, who postulated that the behavior of the whole can be deduced from the qualities of the parts of the whole. Research into illnesses is carried out on the basis of one-directional Gene-phenotype-relations and the living being is mainly viewed as being the expression of the genes.

From an ecological point of view, the parts of a whole can only be viewed in the context of the whole, of the interaction and networking with the environment. Thus, the typing of phenotypes is under epigenetic control (3). The scientific stance is less analytical in nature but more of a context-oriented way of thinking, a view of elements within a system, which is also an environmental way of thinking (4). This is based on a profound ecological awareness and views mankind as a part of the network of all living beings interrelated with nature and not as something apart from or above nature. The new paradigm is based on a new set of values which accepts that each and every living being has an intrinsic value and is an end in itself and rejects the anthrophocentric view of the world (5). We are faced with opposing views on the phenomena of life, on the evaluation of the rest of the world and on the situation of mankind. Thus, the criticism and evaluation of genetic engineering and its effects differ according to the point of view. To some, genetic engineering is the great promise of the future and an irreplaceable part of everyday life in medicine and research, to others, it is an incalculable threat and the expression of contempt for life itself.

We, the Doctors for the Protection of the Environment, consider genetic engineering to be a potentially dangerous instrument if the level of manipulation permitted is not clearly defined and restricted. We believe that due to the high potential of danger and the particular significance of controlled and uncontrolled use of genetic engineering, these decisions must not be taken by scientific commissions and vested interests. We are thus aiming to instigate a public discourse on the subject. In discussing the application of genetic engineering, it is of vital importance to separate the human from the non-human field of application. This is necessary because different goals are pursued in these two fields and there are different interests and danger potentials underlying the use of genetic engineering in these fields.

In the non-human domain, there are questions of ecology, health influences concerning humans and animals, socio-economic and ethical problems which have yet to be resolved. This non-human field overlaps the human field in the production and use of transgenetic animals in medical research, the production of pharmaceuticals and that of organs for xenotransplantation. This means that scientists today must also face and answer theoretical scientific questions on the influence of genetic engineering and its results on society and the world in general and must overcome long-standing taboos. So-called “value-free research“ must be questioned as a form of self-deceit and bioethical considerations should enter into basic research. Sustainable development, i.e. the protection of genetic biodiversity of animal and plant species and the potential danger inherent in the use of genetic engineering, must not be disregarded in favor of short-term economic profits. In the opinion of the Doctors for the Protection of the Environment, the following problems have yet to be resolved.

Ecology (11):
The intentional (according to EU directive 90/220/EWG) or unintentional dissemination of genetically manipulated organisms into an ecosystem represents a risk. There have been a number of efforts to control these potential dangers by risk assessment strategies (6,7,8,9,10). However, by releasing these organisms, the main security barriers of laboratories and production plants are overcome. We are therefore directly and continually exposed to large amounts of genetically engineered organisms (plants, microorganisms, viruses) and are thus subject to an extremely high level of risk (11). The particular quality of risk inherent in genetic engineering resides in the fact that the source of the risk:

  • is alive,
  • reproduces,
  • cannot be retrieved in case of damage
  • and that horizontal transfer of genes can take place
Should any damage occur, retrieval or disinfection is utterly impossible. This fact distinguishes potential damage caused by genetic engineering from risks caused by chemical or nuclear contamination which is limited to certain substances, certain times and certain locations. Genetic engineering turns nature into an open laboratory (11). The different potential dangers have not yet been evaluated (12) and can only be described in terms of quality (13). Experts hold vastly different opinions with regard to risk evaluation (14). Also, the risk assessment carried out to date was mainly based on small-scale tests which, in many parameters (amount, area, time, selective pressure, controllability) are vastly different from large-scale dissemination (15). Long-term effects over centuries cannot be evaluated and risk assessment can only be carried out using model systems. We are thus dealing with hypothetical, incalculable risks (16):
  • with a probability factor of more than zero;
  • in which a cause-effect relationship between the source of the risk and the damage sustained cannot be proven or cannot be proven with absolute certainty;
  • which can result in an intolerably high level of maximum danger;
  • the effects of which can no longer be tested in laboratory tests due to these characteristics.
The risks we are concerned with are the following (Amman Daniel):
  • Transfer of genes by crossing of transgenetic plants with a high transfer of genes with wild species. Example: transgenetic sunflowers, oats or rape.
  • Spontaneous hybridization which takes place more often than expected after genetic manipulation.
  • Transfer of hybrid resistance genes to weeds which would make the herbicide strategy useless in a matter of a few years.
  • Constant or increased use of herbicides and pesticides (according to the expert opinion of the Agricultural Institute of the ETH Zürich, Swiss Institute of Technology)
  • Development of decomposition products harmful to health in transgenetic plant cells (estrogen effect, carcinogenic effect etc.)
  • Transfer of a trans-gene of a plant to other plants (range: a few kilometers) by pollen. Spreading of transgenetic hybrid plants due to selective advantages. Wild plant species becoming considered as weeds.
  • Lasting harm to the ecosystem through invasion by transgenetic plants foreign to the natural environment. The delay in this effect can be up to 200 years.
  • Development of resistances through transgenetic plants resistant to parasites.
    Example: The parasite to which the cotton plant ‘Bt’ (USA) was developed to be resistant nevertheless damaged the plants and destroyed part of the crop.
  • Long-term effects: Due to the lack of definite information provided by theoretical and experimental models, the only possibility of discovering possible negative effects on the eco-system as early on as possible is long-term surveillance. By the time the damage is discovered, these effects may, however, already have become irreversible
  • Impossibility of prevention.
  • Other factors such as horizontal transfer of genes, recombination of viruses and the overstepping of natural barriers such as species make risk assessment impossible. Thus, sustainable development becomes impossible.
Health:
Genetic engineering and its resulting products lead to the introduction of substances into agricultural plants and animals which had hitherto not been present in these organisms. Many sources of potential danger caused by this can be theoretically defined; however, the extent of possible damage is difficult to calculate. The estimation of damage is especially difficult if these products are consumed over a longer period of time.

The products resulting from genetic engineering are new proteins of viral, bacterial, plant or animal origin. Among other things, a potential danger is that these proteins generally do not correspond to the original natural molecule due to differences in the sequence of amino acids. Specialized literature mentions mistakes in the reading of the RNA of up to 20% (17). Furthermore, there is the possibility of absorption of protein and growth hormones through the gastrointestinal tract (18).

Genes may behave differently in different surroundings. Thus, there is evidence that a bovine gene can take on a new shape in an apple genome (19). A tremendous potential of new allergens is created which, according to the FDA, is not predictable due to a lack of required methods (20). Tests have shown that soy plants with a brazil nut gene have caused severe allergic reactions in persons allergic to brazil nuts (21), even though the protein responsible for this (2S-Albumin) was tested as harmless in laboratory (animal) tests. There are still tremendous deficits in allergy research and, as the example mentioned above shows, animal testing is not a reliable method of testing in this case.

Furthermore, similar proteins do not necessarily contain the same allergenic potential. Thus, the protein Tropomyosin found in shrimps is a very strong allergen, while the Tropomyosins found in poultry or beef, which are very similar to the kind found in shrimps, are not (23). The risk of unexpected allergies is greatly increased by genetically engineered plants compared to traditionally grown plants since, due to genetic engineering, not only similar plants but the entire range of plants, animals and many microorganisms is available as a source of genes (24).

Antibiotics resistance genes are linked to the gene concerned in order to make the identification of the successfully treated genes possible. The resulting products of active antibiotics resistance genes which can get into the intestinal tract by the consumption of such foods can deactivate antibiotics given for therapeutic purposes. There is also the possibility that these genes might be transferred to the pathogen germs by the horizontal transfer of genes. The pathogen germs might then acquire that particular resistance and make therapy even more difficult in addition to aggravating the problem of resistance development (25). This seems to be particularly common in microorganisms which carry their new genetic attributes on plasmids which are then added to products of animal and plant origin for further treatment (yogurt, cheese, salami, sauerkraut) (26).

To date, manufacturers have failed to present scientific proof that these problems are manageable. The decomposition products of herbicides in transgenetic plants carry a toxic, carcinogenic and mutagenic potential which is difficult to calculate. In specialized literature, no decisive information on the resulting products of toxin genes in food plants can be found (26). In vitro, the damaging of the erythrocytes by the toxin of the bacillus thuringiensis was proven (27). Positioning effects are also a problem to be dealt with since the introduction of foreign genes into the genome of foodstuffs is necessarily imprecise (11). The final effect of the foreign gene is determined by the context in the receiving genome which makes risk evaluation difficult if not impossible. Such effects have been described in a number of experiments (28,29,30).

New, deviating metabolic processes with undetermined effects may be induced - a number of examples have been described. Genetically engineered L-Tryptophyan led to serious health disorders (Eosinophila-myalgia-syndrome) leading to death (31,32). However, despite intensive research, it is unclear whether this is the effect of genetic engineering or the result of the cleansing process. The broad-spectrum herbicide Glyphosat used on beans had an undesirable estrogen effect in mice (33).

Economic aspects:
Statements on the economic relevance of genetic engineering are controversial and a reliable prognosis of possible economic advantages is next to impossible to create on the basis of currently available data (39). If one takes a closer look at the development in the United States, it becomes evident that any all-too-optimistic forecasts must be viewed with a very critical eye. It is very difficult to access such data for Europe and all too often, biotechnology and genetic engineering are not viewed separately (34).

In the US, genetic engineering makes for 0.1% of the overall job market. This is about the same percentage as in Switzerland. Of the eight million new jobs created in the US during the past four years, only 0.5% are related to genetic engineering. In the Swiss chemical industry, there has been a continual reduction of jobs (34). From this point of view, the relevance of genetic engineering with regard to the job market is not very high. The three chemical industry giants in Basle (Switzerland), Ciba, Sandoz and Roche, have invested about seven billion dollars into genetic engineering in the US from 1990 to 1995 (35), which points to a heavy emphasis being placed on foreign locations The turnovers and losses of the American biotechnology industry (in billion dollars) during recent years were as follows (34):

Losses Turnover
1986 1.4 1.1
1991 2.0 2.9
1996 4.6 9.3

In the US, the emphasis of genetic engineering is in human medicine (about 80%). For obvious reasons, the requirement for investments is very high in genetic engineering. Thus, by comparison to traditional industries, there is a great imbalance between research costs and profit (37). In Germany, each job in genetic engineering is subsidized with 29,000 DM. In Switzerland, too, the development of genetic engineering will be dependent on massive subsidies from the state. Nevertheless, no relevant change of industrial location factors is to be expected during the years to come (38).

Genetically engineered medication can only lead to a relevant increase in turnover if there is a massive amount of new applications and the traditional medication is not merely replaced by a new one (e.g. insulin). Thus, we should be very critical of economic reasons being given for the promotion of genetic engineering.

Social and political implications:
Our economic system is based on the theory of constant growth, unlimited progress and unlimited technological “do-ability“. This has made it possible for us to increase the material wealth of industrial nations. At the same time, however, it has aggravated the social and ecological problems world-wide. This is amply documented in many specialized publications (1,2).

Will genetic engineering show us the way out of this dilemma or will we once again reach an impasse? There are many questions yet to be answered before this question can be resolved.

Is it not - on an economic level - important to know whether extremely costly genetic engineering makes sense on an economic level and whether it is payable for third world countries and whether this would not make them even more dependent on industrialized countries? What about the social implications to be considered when we think of the way society handles these new dangers to health and ecology (co-determination, determination processes, participation)?

What are the consequences to be expected from the distribution of the new products? Will it be possible to ensure the compatibility of security and freedom, the upkeep of traditional, grown social systems such as small farmers, primitive tribes etc.? Will the new genetically engineered products even be affordable for the people in poor countries or will this only increase the wealth gap between north and south? Is medication and are diagnostic products produced by genetic engineering (Gene-farming) of any importance for the greater part of mankind on a health-political level in view of the fact that morbidity and mortality rates in the third world could be significantly reduced by an increase of wealth, hygiene, education, equal rights for women and a healthy diet?

Would it not be possible to reduce hunger and famine world-wide on a massive scale by measures such as a different food policy in the sense of a drastic reduction of the production of foodstuffs for meat production in favor of the cultivation of plants for human consumption? 86% of the plant crop world-wide is used for meat production, where 90% of primary energy is lost (39)! Does not the introduction of standardized, genetically engineered plants promote mono-cultures with all their well-known negative effects? The spreading of mixed cultures with indigenous plants and ecological farming would instead promote the development of smaller social units and contribute greatly to the upkeep of bio-diversity and resistance of strains. Should not food production be taken back to its origins instead of changing plants by genetic engineering so that they can, in fact, grow in places where they would not naturally thrive?

We, the Doctors for the Protection of the Environment, are convinced that these socio-political questions as well as many other questions not mentioned here must be answered before we initiate mechanisms which we are no longer able to control.

Transgenetic animals and ethical considerations:
By producing and using transgenetic animals, science has entered a stage which is no longer accepted without criticism. This holds true for the economic and scientific aspects but even more for the ethical and moral aspects. Risk evaluation, especially in xenotransplantation, is impossible. How, for instance, can the harmlessness of viruses transferred from animals to humans through xenotransplantation be proven if we do not even know that these viruses exist (40,41)? The Swiss Science Council (Schweizerischer Wissenschaftsrat) has worked out a questionnaire with regard to transgenetic animals and has come to the conclusion that the importance of transgenetic animals in researching human diseases cannot yet be clearly evaluated (42). The discussion on the scientific aspect of genetic engineering of animals would exceed the limits of this article by far. I will therefore only discuss the ethical aspects.

The highest good of any living being is its individual life and its greatest interest is not to lose that life - I believe this dogma remains undisputed. Every individual living being also has a right to its own specific dignity which is guaranteed to all creatures by the Swiss Constitution (Bundesverfassung, Art. 24 Novies Abs. 3). We know what human dignity is, but how does one define the dignity of animals? Is dignity something which has a different hierarchical level depending on the individual being? This would imply that the value of life and dignity is different according to species. Or is there a special dignity of every species which is different from but of the same value as human dignity?

Depending on the philosophical-religious position, there are different opinions on this. Thus, J. Schenkel (43) represents the anthropocentric point of view: “Transgenetic experiments can certainly be described as justified if they contribute to the understanding of the way serious or incurable illnesses work or if they contribute to basic research, if these questions cannot otherwise be answered. The use of transgenetic animals for the production of pharmaceutics is also acceptable.” The science advisory board of the environmental representative of the Council of the Protestant Church of Germany 1991 takes quite the opposite stance (44):

“The use of animals is only acceptable if it is not associated with pain or suffering to the benefit of greater production for mankind and if the dignity of the animal is ensured. The life of animals is also to be protected. The killing of animals is only admissible as an act of mercy in order to end incurable suffering or in self-defense or similarly extreme situations”.

In his study of 62 authors who have written on the dignity of man and our fellow creatures, G.M.Teutsch (44) draws the following conclusion: “The dignity of animals is endangered or violated if the fact that they are animals, that they are what they are and their development potential is not accepted but changed and if the animal is mostly regarded as a means to an end and not as an end in itself. This is especially true of genetic engineering performed on animals and when animals are degraded to simple instruments of measurement as is done in toxicity tests “. We, the Doctors for the Protection of the Environment, fully support this thesis and are of the opinion that the dignity of man and animals is inseparably linked. Animals have their own value and represent an end in themselves which is independent of the consumer interests of mankind and thus have a dignity of their own. Teutsch writes (44):

“The dignity of animals demands that we respect their individual value which is independent of our methods of valuation. Only humans capable of insight are in a position to respect this. To be led in one’s actions by the well-being of other creatures is therefore always also a question of the view we take of ourselves and of the world we live in and thus, in the end, is also a question of human dignity”. This point of view has far-reaching consequences and demands that our society renounce advantages and possible advantages in the field of research, medicine and economy if this will serve the respect of the dignity of animals and if the suffering of animals can thus be prevented.

This demand is even more relevant since experience has shown that animal models can only lead us to successful therapies for human illnesses on a very basic level (e.g. the oncomouse, the cystic fibrosis mouse etc.). It is true that the number of animals used in individual laboratory tests can be reduced by using transgenetic models. However, due to the greatly extended use of transgenetic models it appears that overall, there will be more laboratory tests involving animals (45). The creation of a transgenetic animal represents a great burden to the animal itself (45) and the number of suffering animals bred in this state has greatly increased due to genetic engineering (42). We reject the weighing of human profit against animal suffering because genetic manipulation carried out on animals and the suffering incurred in these animals in itself violates the dignity of the animals. We consider alternatives on the level of cellular and molecular biological methods of genetic engineering to be an adequate replacement for transgenetic animals and demand that the emphasis of investment be placed on this field of biotechnology and genetic engineering.

Conclusion:
The development of biotechnology has been taking place at breakneck speed which has reached its most portentous form in genetic engineering. Mankind is not prepared for this development and is being overrun by it. We have far too little information on the principles and consequences of genetic engineering because development is taking place far too quickly and the entire subject is not transparent enough. The vested interests of science, medicine and industry are so tremendous that the development of a huge lobby in favor of genetic engineering has gone almost unnoticed. There are more and more extremely specialized experts working in these fields who know ever more about ever less and these people are using their specialized know-how in an area which is dangerous to the integrity of mankind and nature.

After nuclear power, science has once again reached a limit which it must not overstep without the assent of society, however utopian this might sound. Due to the extent of the implications of genetic engineering for man and nature, this decision must not be left to the experts and councils of ethics which recruit their members from the scientific community, but it must be discussed on a very basic level and very openly throughout all levels of society. In the decision-making process, representatives of all interest groups must participate on an equal level. This might possibly put into perspective a very lopsided, anthropocentrically founded argumentation on the basis of usefulness. In particular, we need new ecological and social standards which allow for the value and the dignity of our fellow creatures even if this means that mankind must renounce the benefits of certain pieces of new knowledge.

The upcoming genetic protection initiative (Gen-Schutz-Initiative) gives us an opportunity to initiate this dialog in Switzerland.

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Translated into English by: Eva Stabenow - EVStabenow@aol.com